Connect-Home Clinical Trial

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Completed
• CT.gov ID: NCT03810534
• Collaborator: National Institute of Nursing Research (NINR) (NIH)
• Enrollment: 654
• Location: 1
• Arms: 2
• Actual Duration (Months): 30.4
• Patients Per Site Per Month: 21.5

Study Details

Study Description

Brief Summary

This study will test whether transitional care targeting care needs of seriously ill, skilled nursing facility (SNF) patients and their caregivers will help to improve SNF patient outcomes (preparedness for discharge, quality of life, function and acute care use) and caregiver outcomes (preparedness for the caregiving role. caregiver burden and caregiver distress).

Condition or Disease	Intervention/Treatment	Phase
Transitional Care; Caregivers; Patient Discharge; Aging; Frailty	Behavioral: Connect-Home	N/A

Detailed Description

Prior research has not established an evidence-based model of transitional care for seriously ill SNF patients (and their caregivers) who transfer from SNF to home-based care. Connect-Home, the intervention to be tested in this study, will use existing nursing home staff and community-based nurses to deliver transitional care in SNFs and the patient's home.

The feasibility, acceptability, and estimated efficacy of Connect-Home was demonstrated in a pilot test of pre-discharge elements of Connect-Home (N=133 patients and their caregivers). Compared to controls, intervention participants were significantly more prepared for discharge (higher scores on Care Transitions Measure-15) and they more frequently received individualized plans for continuing care at home. Virtually all SNF staff participants (97%) recommended the intervention for future use, demonstrating its acceptability. The objective of this study is to test the efficacy of Connect-Home for seriously ill patients discharged to home and their caregivers.

In this trial, intervention participants will receive the Connect-Home intervention; the intervention has two steps. While the patient is in the SNF, nurses, social workers and rehabilitation therapists will create an individualized Transition Plan of Care and prepare the patient and caregiver to manage the patient's serious illness at home. Within 24 hours of the time that the SNF patient discharges to home, a Connect-Home Activation Nurse (Activation RN) will visit the patient at home; the Activation RN will help the patient and family caregiver implement the written Transition Plan of Care. The Connect-Home intervention will focus on six key care needs: (1) home safety and level of assistance; (2) advance care planning; (3) symptom management; (4) medication reconciliation; (5) function and activity; and (6) coordination of follow-up medical care. In this trial, the control participants will receive usual discharge planning in the SNF only. Usual discharge planning for SNF patients includes assignment to an interdisciplinary team that develops discharge instructions for the patient to follow at home with oversight by a physician. Usual care does not include a structured home visit after the patient discharges to home.

Patient and caregiver outcomes will assessed in 7, 30, and 60 days after the patient discharged from the SNF to home. Outcomes assessors will be blinded to study group.

Study Design

• Study Type: Interventional
• Actual Enrollment: 654 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: The Connect-Home study employs a stepped wedge cluster-randomized trial design, which is a crossover design at the cluster level where clusters of individuals (i.e., residents in a nursing home) crossover from control to intervention condition at randomly assigned timepoints or steps.The Connect-Home study employs a stepped wedge cluster-randomized trial design, which is a crossover design at the cluster level where clusters of individuals (i.e., residents in a nursing home) crossover from control to intervention condition at randomly assigned timepoints or steps.
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Connect-Home: Testing the Efficacy of Transitional Care of Patients and Caregivers During Transitions From Skilled Nursing Facilities to Home
• Actual Study Start Date: Mar 1, 2019
• Actual Primary Completion Date: Jul 24, 2021
• Actual Study Completion Date: Sep 12, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Connect-Home Connect-Home intervention at the skilled nursing facility and at the subject's home.	Behavioral: Connect-Home; Connect-Home will introduce organizational structure to support delivery of transitional care processes. New elements of structure include:electronic health record (EHR) template, Connect-Home Toolkit, and Staff Training. After structural elements are added, SNF staff will use Connect-Home care processes to deliver the 2-step transitional care intervention.In Step 1, SNF nurses, therapists, and social workers will develop a Transition Plan of Care and prepare the patient and caregiver to manage the patient's serious illness and functional needs. In Step 2, the Connect-Home Activation RN will visit the patient's home within 24 hours of discharge; the nurse will activate the Transition Plan of Care at home. Both intervention steps focus on 6 key care needs to optimize patient and caregiver outcomes: 1) home safety and level of assistance; 2) advance care planning; 3) symptom management; 4) medication reconciliation; 5) function and activity; and 6) coordination of follow-up medical care.
No Intervention: Control Standard discharge planning at the skilled nursing facility only.

Outcome Measures

Primary Outcome Measures

1. Care Transitions Measure-15 Score 7 Days After Skilled Nursing Facility Discharge [7 Days After SNF Discharge]

   The patient's preparedness for discharge will be measured by the Care Transitions Measure-15 (CTM-15), which includes 5 items on a 4-point scale. The CTM-15 measures self-reported knowledge and skills for continuing care at home. Summary score range 0-100, with higher scores associated with less acute care use after discharge.

2. Preparedness for Caregiving Scale Score 7 Days After Patient's Skill Nursing Facility Discharge [7 Days After Patient SNF Discharge]

   The caregiver's preparedness for caregiving will be measured by the Preparedness for Caregiving Scale (PCS), which includes 8 items on a five-point Likert scale (0-4). The PCS measures self-reported readiness for caregiving. Range = 0-32, with higher scores associated with less anxiety.

Secondary Outcome Measures

1. McGill Quality of Life Questionnaire-Revised Score 30 Days After Skilled Nursing Facility Discharge [30 Days After SNF Discharge]

   The patient's quality of life will be measured using the McGill Quality of Life Questionnaire-Revised (MQoL-R), which includes 14 items on a ten-point Likert scale. The scale is recommended for studies of palliative care and measures quality of life across disease trajectories. Range = 0-10, with higher score indicating better quality of life. There are 4 MQOL-R subscales. Each subscale score is the mean of its items that range from 0-10. The Total Score, also ranging from 0-10, is the mean of the subscale score means.

2. McGill Quality of Life Questionnaire-Revised Score 60 Days After Skilled Nursing Facility Discharge [60 Days After SNF Discharge]

   The patient's quality of life will be measured using the McGill Quality of Life Questionnaire-Revised (MQoL-R), which includes 14 items on a ten-point Likert scale. The scale is recommended for studies of palliative care and measures quality of life across disease trajectories. Range = 0-10, with higher score indicating better quality of life. There are 4 MQOL-R subscales. Each subscale score is the mean of its items that range from 0-10. The Total Score, also ranging from 0-10, is the mean of the subscale score means.

3. Life Space Assessment 30 Days After Skilled Nursing Facility Discharge [30 Days After SNF Discharge]

   Patient's function will be measured using the Life Space Assessment, which includes 5 Likert scales corresponding to a hierarchy of levels of mobility (each scored from 0-4) where weights are the product of the "Life-space level" (range 1-5) and the "independence" score (range 1-2). The range is 1-120. Lower scores are associated with falls and hospitalization.

4. Life Space Assessment 60 Days After Skilled Nursing Facility Discharge [60 Days After SNF Discharge]

   Patient's function will be measured using the Life Space Assessment, which includes 5 Likert scales corresponding to a hierarchy of levels of mobility (each scored from 0-4) where weights are the product of the "Life-space level" (range 1-5) and the "independence" score (range 1-2). The range is 1-120. Lower scores are associated with falls and hospitalization.

5. Zarit Caregiver Burden Scale 30 Days After Skilled Nursing Facility Discharge [30 Days After Patient's SNF Discharge]

   Caregiver burden will be measured using the Zarit Caregiver Burden Scale, which includes 12 items on a five-point scale, measuring caregiver perceptions that "caregiving has an adverse effect on their emotional, social, financial, physical and spiritual functioning." Scores range 0-48; higher scores are associated with depression and social isolation.

6. Zarit Caregiver Burden Scale 60 Days After Skilled Nursing Facility Discharge [60 Days After Patient's SNF Discharge]

   Caregiver burden will be measured using the Zarit Caregiver Burden Scale, which includes 12 items on a five-point scale, measuring caregiver perceptions that "caregiving has an adverse effect on their emotional, social, financial, physical and spiritual functioning." Scores range 0-48; higher scores are associated with depression and social isolation.

7. Distress Thermometer 30 Days After Skilled Nursing Facility Discharge [30 Days After Patient's SNF Discharge]

   Caregiver distress will be measured using the Distress Thermometer, which includes 1 item on an 11-point scale, measuring negative affect (e.g., sadness and fear) related to caregiving for a severely ill person. Score ranges 0-10, with scores >4 associated with poor coping and depression.

8. Distress Thermometer 60 Days After Skilled Nursing Facility Discharge [60 Days After Patient's SNF Discharge]

   Caregiver distress will be measured using the Distress Thermometer, which includes 1 item on an 11-point scale, measuring negative affect (e.g., sadness and fear) related to caregiving for a severely ill person. Score ranges 0-10, with scores >4 associated with poor coping and depression.

9. Self-Reported Days of ED or Hospital Use 30 Days After Skilled Nursing Facility Discharge [30 Days After SNF Discharge]

   Patient's days of acute care use will be measured using the self-reported number of combined number of days the patient spends in the Emergency Department (ED) or hospital in 30 days after SNF discharge.

10. Self-Reported Days of ED or Hospital Use 60 Days After Skilled Nursing Facility Discharge [60 Days After SNF Discharge]

    Patient's days of acute care use will be measured using the self-reported number of combined number of days the patient spends in the ED or hospital in 60 days after SNF discharge.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria for patients:

• English-speaking

• Have a Minimum Data Set 3.0 Section GG Mobility Assessment Score of 3 or less, indicating the patient requires at least 25-50% assistance for functional mobility

• Be diagnosed with at least 1 serious medical illness (neurodegenerative dementia, cancer, chronic kidney disease, cirrhosis, congestive heart failure, chronic obstructive or interstitial lung disease, acute infection with sepsis, acute major motor stroke, acute coronary syndrome, acute hip fracture, diabetes with end organ complications, or intensive care for >3 days while hospitalized)

• Having a caregiver who can be enrolled in the study

• For patients with cognitive impairment additional criteria include documentation in the medical record of a caregiver who is the patient's legally authorized representative; and consent of the caregiver to participate in the study as the patient's representative.

Inclusion Criteria for Caregivers:

• English-speaking

• Self-reports assisting the patient at home.

Exclusion Criteria for Patients:

• Planned hospital readmission for procedures/treatments in next 90 days.

There are no exclusion criteria for Caregivers.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UNC-Chapel Hill	Chapel Hill	North Carolina	United States	27599

Sponsors and Collaborators

• University of North Carolina, Chapel Hill
• National Institute of Nursing Research (NINR)

Investigators

• Principal Investigator: Mark Toles, PhD, RN, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 13, 2020
• Informed Consent Form - Jan 30, 2019

More Information

Publications

None provided.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT03810534
• Other Study ID Numbers: 18-1513; R01NR017636
• First Posted: Jan 18, 2019
• Last Update Posted: Aug 23, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of North Carolina, Chapel Hill: Transitional Care; Skilled Nursing Facilities
• Additional relevant MeSH terms: Frailty

Study Results

Participant Flow

Arm/Group Title	SNF 1	SNF 2	SNF 3	SNF 4	SNF 5	SNF 6
Arm/Group Description	Connect-Home intervention at skilled nursing facility (SNF) 1. Participants at this SNF enter the Standard of Care phase for 5 months, the Pre-Implementation phase for 2 months and the Connect-Home phase for 11 months. Participants will encounter discharge planning at the skilled nursing facility and will have data collected at 7, 30, and 60 days post SNF discharge.	Connect-Home intervention at skilled nursing facility (SNF) 2. Participants at this SNF enter the Standard of Care phase for 6 months, the Pre-Implementation phase for 2 months and the Connect-Home phase for 10 months. Participants will encounter discharge planning at the skilled nursing facility and will have data collected at 7, 30, and 60 days post SNF discharge.	Connect-Home intervention at skilled nursing facility (SNF) 3. Participants at this SNF enter the Standard of Care phase for 7 months, the Pre-Implementation phase for 2 months and the Connect-Home phase for 9 months. Participants will encounter discharge planning at the skilled nursing facility and will have data collected at 7, 30, and 60 days post SNF discharge.	Connect-Home intervention at skilled nursing facility (SNF) 4. Participants at this SNF enter the Standard of Care phase for 8 months, the Pre-Implementation phase for 2 months and the Connect-Home phase for 8 months. Participants will encounter discharge planning at the skilled nursing facility and will have data collected at 7, 30, and 60 days post SNF discharge.	Connect-Home intervention at skilled nursing facility (SNF) 5. Participants at this SNF enter the Standard of Care phase for 9 months, the Pre-Implementation phase for 2 months and the Connect-Home phase for 7 months. Participants will encounter discharge planning at the skilled nursing facility and will have data collected at 7, 30, and 60 days post SNF discharge.	Connect-Home intervention at skilled nursing facility (SNF) 6. Participants at this SNF enter the Standard of Care phase for 10 months, the Pre-Implementation phase for 2 months and the Connect-Home phase for 6 months. Participants will encounter discharge planning at the skilled nursing facility and will have data collected at 7, 30, and 60 days post SNF discharge.
Period Title: Standard of Care (5-10 Months)
STARTED	40	46	54	62	34	88
Patients Started	20	23	27	31	17	44
Caregivers Started	20	23	27	31	17	44
Completed 7-day (Patients)	16	20	23	29	13	40
Completed 7-Day (Caregivers)	18	21	23	29	13	38
Completed 30-day (Patients)	14	16	21	23	12	38
Completed 30-Day (Caregivers)	14	16	21	23	10	32
Completed 60-Day (Patients)	10	16	17	20	10	32
Completed 60-Day (Caregivers)	10	16	15	20	9	31
COMPLETED	20	32	32	40	19	63
NOT COMPLETED	20	14	22	22	15	25
Period Title: Standard of Care (5-10 Months)
STARTED	0	0	0	0	0	0
Patients Started	0	0	0	0	0	0
Caregivers Started	0	0	0	0	0	0
Completed 7-Day (Patients)	0	0	0	0	0	0
Completed 7-Day (Caregivers)	0	0	0	0	0	0
Completed 30-Day (Patients)	0	0	0	0	0	0
Completed 30-Day (Caregivers)	0	0	0	0	0	0
Completed 60-Day (Patients)	0	0	0	0	0	0
Completed 60-Day (Caregivers)	0	0	0	0	0	0
COMPLETED	0	0	0	0	0	0
NOT COMPLETED	0	0	0	0	0	0
Period Title: Standard of Care (5-10 Months)
STARTED	82	80	66	54	10	38
Patients Started	41	40	33	27	5	19
Caregivers Started	41	40	33	27	5	19
Completed 7-Day (Patients)	38	35	27	23	4	14
Completed 7-Day (Caregivers)	35	34	29	24	4	13
Completed 30-Day (Patients)	35	31	25	19	3	12
Completed 30-Day (Caregivers)	34	30	25	21	2	10
Completed 60-Day (Patients)	30	25	23	19	2	10
Completed 60-Day (Caregivers)	32	27	21	19	2	9
COMPLETED	62	52	44	38	4	19
NOT COMPLETED	20	28	22	16	6	19

Baseline Characteristics

Arm/Group Title	Connect-Home Patients	Connect-Home Caregivers	Control Patients	Control Caregivers	Total
Arm/Group Description	Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.	Caregivers of Connect-Home study patients.	Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge.	Caregivers of Control study patients.	Total of all reporting groups
Overall Participants	165	165	162	162	654
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	76.5 (9.49)	58.1 (14.02)	76.6 (9.55)	60.9 (13.72)	76.5 (9.51)
Sex: Female, Male (Count of Participants)
Female	104 63%	119 72.1%	105 64.8%	116 71.6%	444 67.9%
Male	61 37%	46 27.9%	57 35.2%	46 28.4%	210 32.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	165 100%	165 100%	162 100%	162 100%	654 100%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	37 22.4%	37 22.4%	40 24.7%	43 26.5%	157 24%
White	123 74.5%	117 70.9%	119 73.5%	113 69.8%	472 72.2%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	5 3%	11 6.7%	3 1.9%	6 3.7%	25 3.8%
Region of Enrollment (Count of Participants)
United States	165 100%	165 100%	162 100%	162 100%	654 100%

Outcome Measures

1. Primary Outcome

Title	Care Transitions Measure-15 Score 7 Days After Skilled Nursing Facility Discharge
Description	The patient's preparedness for discharge will be measured by the Care Transitions Measure-15 (CTM-15), which includes 5 items on a 4-point scale. The CTM-15 measures self-reported knowledge and skills for continuing care at home. Summary score range 0-100, with higher scores associated with less acute care use after discharge.
Time Frame	7 Days After SNF Discharge

Outcome Measure Data

Analysis Population Description

Data reported for participants who answered the 7-day data collection phone call.

Arm/Group Title	Connect-Home	Control
Arm/Group Description	Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.	Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge
Measure Participants	142	141
Mean (Standard Deviation) [score on a scale]	75.80 (16.08)	68.33 (17.69)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Connect-Home, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.62
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.64
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.24
	Estimation Comments	The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.

2. Primary Outcome

Title	Preparedness for Caregiving Scale Score 7 Days After Patient's Skill Nursing Facility Discharge
Description	The caregiver's preparedness for caregiving will be measured by the Preparedness for Caregiving Scale (PCS), which includes 8 items on a five-point Likert scale (0-4). The PCS measures self-reported readiness for caregiving. Range = 0-32, with higher scores associated with less anxiety.
Time Frame	7 Days After Patient SNF Discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Connect-Home	Control
Arm/Group Description	Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.	Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge
Measure Participants	140	141
Mean (Standard Deviation) [score on a scale]	23.14 (6.74)	19.26 (6.42)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Connect-Home, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.31
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.47
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.44
	Estimation Comments	The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.

3. Secondary Outcome

Title	McGill Quality of Life Questionnaire-Revised Score 30 Days After Skilled Nursing Facility Discharge
Description	The patient's quality of life will be measured using the McGill Quality of Life Questionnaire-Revised (MQoL-R), which includes 14 items on a ten-point Likert scale. The scale is recommended for studies of palliative care and measures quality of life across disease trajectories. Range = 0-10, with higher score indicating better quality of life. There are 4 MQOL-R subscales. Each subscale score is the mean of its items that range from 0-10. The Total Score, also ranging from 0-10, is the mean of the subscale score means.
Time Frame	30 Days After SNF Discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Connect-Home	Control
Arm/Group Description	Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.	Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge
Measure Participants	100	91
Mean (Standard Deviation) [score on a scale]	7.69 (1.81)	7.69 (1.79)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Connect-Home, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.93
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	.03
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .33
	Estimation Comments	The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.

4. Secondary Outcome

Title	McGill Quality of Life Questionnaire-Revised Score 60 Days After Skilled Nursing Facility Discharge
Description	The patient's quality of life will be measured using the McGill Quality of Life Questionnaire-Revised (MQoL-R), which includes 14 items on a ten-point Likert scale. The scale is recommended for studies of palliative care and measures quality of life across disease trajectories. Range = 0-10, with higher score indicating better quality of life. There are 4 MQOL-R subscales. Each subscale score is the mean of its items that range from 0-10. The Total Score, also ranging from 0-10, is the mean of the subscale score means.
Time Frame	60 Days After SNF Discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Connect-Home	Control
Arm/Group Description	Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.	Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge
Measure Participants	88	81
Mean (Standard Deviation) [score on a scale]	7.81 (1.58)	7.71 (1.73)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Connect-Home, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.60
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	.18
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .34
	Estimation Comments	The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.

5. Secondary Outcome

Title	Life Space Assessment 30 Days After Skilled Nursing Facility Discharge
Description	Patient's function will be measured using the Life Space Assessment, which includes 5 Likert scales corresponding to a hierarchy of levels of mobility (each scored from 0-4) where weights are the product of the "Life-space level" (range 1-5) and the "independence" score (range 1-2). The range is 1-120. Lower scores are associated with falls and hospitalization.
Time Frame	30 Days After SNF Discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Connect-Home	Control
Arm/Group Description	Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.	Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge
Measure Participants	124	125
Mean (Standard Deviation) [score on a scale]	22.18 (16.67)	22.97 (15.38)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Connect-Home, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.53
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.24
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.49
	Estimation Comments	The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.

6. Secondary Outcome

Title	Life Space Assessment 60 Days After Skilled Nursing Facility Discharge
Description	Patient's function will be measured using the Life Space Assessment, which includes 5 Likert scales corresponding to a hierarchy of levels of mobility (each scored from 0-4) where weights are the product of the "Life-space level" (range 1-5) and the "independence" score (range 1-2). The range is 1-120. Lower scores are associated with falls and hospitalization.
Time Frame	60 Days After SNF Discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Connect-Home	Control
Arm/Group Description	Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.	Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge
Measure Participants	108	105
Mean (Standard Deviation) [score on a scale]	25.55 (17.41)	28.60 (18.55)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Connect-Home, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.83
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	.78
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.57
	Estimation Comments	The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.

7. Secondary Outcome

Title	Zarit Caregiver Burden Scale 30 Days After Skilled Nursing Facility Discharge
Description	Caregiver burden will be measured using the Zarit Caregiver Burden Scale, which includes 12 items on a five-point scale, measuring caregiver perceptions that "caregiving has an adverse effect on their emotional, social, financial, physical and spiritual functioning." Scores range 0-48; higher scores are associated with depression and social isolation.
Time Frame	30 Days After Patient's SNF Discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Connect-Home	Control
Arm/Group Description	Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.	Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge
Measure Participants	120	118
Mean (Standard Deviation) [score on a scale]	12.27 (9.77)	12.33 (10.33)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Connect-Home, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.75
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	.67
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.05
	Estimation Comments	The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.

8. Secondary Outcome

Title	Zarit Caregiver Burden Scale 60 Days After Skilled Nursing Facility Discharge
Description	Caregiver burden will be measured using the Zarit Caregiver Burden Scale, which includes 12 items on a five-point scale, measuring caregiver perceptions that "caregiving has an adverse effect on their emotional, social, financial, physical and spiritual functioning." Scores range 0-48; higher scores are associated with depression and social isolation.
Time Frame	60 Days After Patient's SNF Discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Connect-Home	Control
Arm/Group Description	Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.	Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge
Measure Participants	106	102
Mean (Standard Deviation) [score on a scale]	11.84 (9.40)	11.35 (8.94)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Connect-Home, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.50
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.44
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.07
	Estimation Comments	The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.

9. Secondary Outcome

Title	Distress Thermometer 30 Days After Skilled Nursing Facility Discharge
Description	Caregiver distress will be measured using the Distress Thermometer, which includes 1 item on an 11-point scale, measuring negative affect (e.g., sadness and fear) related to caregiving for a severely ill person. Score ranges 0-10, with scores >4 associated with poor coping and depression.
Time Frame	30 Days After Patient's SNF Discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Connect-Home	Control
Arm/Group Description	Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.	Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge
Measure Participants	118	118
Mean (Standard Deviation) [score on a scale]	3.19 (2.66)	3.02 (3.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Connect-Home, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.48
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	.36
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .50
	Estimation Comments	The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.

10. Secondary Outcome

Title	Distress Thermometer 60 Days After Skilled Nursing Facility Discharge
Description	Caregiver distress will be measured using the Distress Thermometer, which includes 1 item on an 11-point scale, measuring negative affect (e.g., sadness and fear) related to caregiving for a severely ill person. Score ranges 0-10, with scores >4 associated with poor coping and depression.
Time Frame	60 Days After Patient's SNF Discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Connect-Home	Control
Arm/Group Description	Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.	Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge
Measure Participants	105	102
Mean (Standard Deviation) [score on a scale]	3.03 (3.07)	2.60 (2.73)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Connect-Home, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.22
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	.65
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .52
	Estimation Comments	The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.

11. Secondary Outcome

Title	Self-Reported Days of ED or Hospital Use 30 Days After Skilled Nursing Facility Discharge
Description	Patient's days of acute care use will be measured using the self-reported number of combined number of days the patient spends in the Emergency Department (ED) or hospital in 30 days after SNF discharge.
Time Frame	30 Days After SNF Discharge

Outcome Measure Data

Analysis Population Description

Data are reported only for participants who had acute care use.

Arm/Group Title	Connect-Home	Control
Arm/Group Description	Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.	Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge.
Measure Participants	135	130
Mean (Standard Deviation) [Days]	.65 (1.82)	1.01 (3.46)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Connect-Home, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.88
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean ratio
	Estimated Value	.96
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .25
	Estimation Comments

12. Secondary Outcome

Title	Self-Reported Days of ED or Hospital Use 60 Days After Skilled Nursing Facility Discharge
Description	Patient's days of acute care use will be measured using the self-reported number of combined number of days the patient spends in the ED or hospital in 60 days after SNF discharge.
Time Frame	60 Days After SNF Discharge

Outcome Measure Data

Analysis Population Description

Data are reported only for participants who had acute care use.

Arm/Group Title	Connect-Home	Control
Arm/Group Description	Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.	Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge.
Measure Participants	136	131
Mean (Standard Error) [Days]	.82 (2.00)	1.24 (3.61)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Connect-Home, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.23
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean ratio
	Estimated Value	.72
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .18
	Estimation Comments

Adverse Events

Time Frame	Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.
Adverse Event Reporting Description	Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.
Arm/Group Title	Connect-Home Patients		Connect-Home Caregivers		Control Patients		Control Caregivers
Arm/Group Description	Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.		Caregivers of Connect-Home study patients.		Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge.		Caregivers of Control study patients.
All Cause Mortality
	Connect-Home Patients		Connect-Home Caregivers		Control Patients		Control Caregivers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/165 (3.6%)		0/165 (0%)		8/162 (4.9%)		0/162 (0%)
Serious Adverse Events
	Connect-Home Patients		Connect-Home Caregivers		Control Patients		Control Caregivers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	38/165 (23%)		0/165 (0%)		34/162 (21%)		0/162 (0%)
Blood and lymphatic system disorders
Hospitalization Due to Sepsis	1/165 (0.6%)	1	0/165 (0%)	0	0/162 (0%)	0	0/162 (0%)	0
Cardiac disorders
Hospitalization for Racing Heart Issues	1/165 (0.6%)	1	0/165 (0%)	0	0/162 (0%)	0	0/162 (0%)	0
Hospitalization Due to Low Blood Pressure	1/165 (0.6%)	1	0/165 (0%)	0	0/162 (0%)	0	0/162 (0%)	0
Hospitalization Due to Fluid Build-Up	2/165 (1.2%)	2	0/165 (0%)	0	1/162 (0.6%)	1	0/162 (0%)	0
Hospitalization Due to Left Thoracentesis	1/165 (0.6%)	1	0/165 (0%)	0	0/162 (0%)	0	0/162 (0%)	0
Hospitalization Due to Atrial Fibrillation	1/165 (0.6%)	1	0/165 (0%)	0	0/162 (0%)	0	0/162 (0%)	0
Hospitalization Due to Cardiac Stent Placement	1/165 (0.6%)	1	0/165 (0%)	0	0/162 (0%)	0	0/162 (0%)	0
Hospitalization Due to Congestive Heart Failure	1/165 (0.6%)	1	0/165 (0%)	0	1/162 (0.6%)	1	0/162 (0%)	0
Hospitalization Due to Pulmonary Embolism	0/165 (0%)	0	0/165 (0%)	0	1/162 (0.6%)	1	0/162 (0%)	0
Hospitalization Due to Chest Pain	0/165 (0%)	0	0/165 (0%)	0	1/162 (0.6%)	1	0/162 (0%)	0
Gastrointestinal disorders
Hospitalization Due to Colon Tear	1/165 (0.6%)	1	0/165 (0%)	0	0/162 (0%)	0	0/162 (0%)	0
Hospitalization Due to Abdominal Pain	0/165 (0%)	0	0/165 (0%)	0	1/162 (0.6%)	1	0/162 (0%)	0
General disorders
Hospitalization for generalized weakness	1/165 (0.6%)	1	0/165 (0%)	0	0/162 (0%)	0	0/162 (0%)	0
Hospitalization Reason Undisclosed	3/165 (1.8%)	3	0/165 (0%)	0	2/162 (1.2%)	2	0/162 (0%)	0
Hepatobiliary disorders
Hospitalization Due to Gall Bladder Issues	1/165 (0.6%)	1	0/165 (0%)	0	0/162 (0%)	0	0/162 (0%)	0
Musculoskeletal and connective tissue disorders
Hospitalization Due to Fracture Subsequent to Fall	8/165 (4.8%)	8	0/165 (0%)	0	4/162 (2.5%)	4	0/162 (0%)	0
Hospitalization Due to Lower Extremity Weakness	0/165 (0%)	0	0/165 (0%)	0	1/162 (0.6%)	1	0/162 (0%)	0
Hospitalization Due to Leg Pain	0/165 (0%)	0	0/165 (0%)	0	1/162 (0.6%)	1	0/162 (0%)	0
Nervous system disorders
Hospitalization due to Mini Stroke	1/165 (0.6%)	1	0/165 (0%)	0	2/162 (1.2%)	2	0/162 (0%)	0
Hospitalization Due to Acute Metabolic Encephalopathy	1/165 (0.6%)	1	0/165 (0%)	0	0/162 (0%)	0	0/162 (0%)	0
Hospitalization Due to Tremors	0/165 (0%)	0	0/165 (0%)	0	1/162 (0.6%)	1	0/162 (0%)	0
Renal and urinary disorders
Hospitalization due to Urinary Tract Infection	5/165 (3%)	5	0/165 (0%)	0	4/162 (2.5%)	4	0/162 (0%)	0
Hospitalization due to Kidney Issues	2/165 (1.2%)	2	0/165 (0%)	0	1/162 (0.6%)	1	0/162 (0%)	0
Respiratory, thoracic and mediastinal disorders
Hospitalization Due to Shortness of Breath	1/165 (0.6%)	1	0/165 (0%)	0	4/162 (2.5%)	4	0/162 (0%)	0
Hospitalization Due to Pneumonia	0/165 (0%)	0	0/165 (0%)	0	6/162 (3.7%)	6	0/162 (0%)	0
Skin and subcutaneous tissue disorders
Hospitalization for Neck Laceration Caused by Fall	1/165 (0.6%)	1	0/165 (0%)	0	0/162 (0%)	0	0/162 (0%)	0
Hospitalization Due to Skin Infection	3/165 (1.8%)	3	0/165 (0%)	0	1/162 (0.6%)	1	0/162 (0%)	0
Surgical and medical procedures
Hospitalization Due to Toe Amputation	0/165 (0%)	0	0/165 (0%)	0	2/162 (1.2%)	2	0/162 (0%)	0
Vascular disorders
Hospitalization Due to Vasculitis	1/165 (0.6%)	1	0/165 (0%)	0	0/162 (0%)	0	0/162 (0%)	0
Other (Not Including Serious) Adverse Events
	Connect-Home Patients		Connect-Home Caregivers		Control Patients		Control Caregivers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/165 (0%)		0/165 (0%)		0/162 (0%)		0/162 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.